FDA 483 - Wedgewood Village Pharmacy, LLC - March 24, 2022

During a March 14-24, 2022 inspection, the FDA issued a Form 483 to Wedgewood Village Pharmacy, LLC, a producer of sterile and non-sterile drug products. The observations highlight significant deviations from manufacturing practices, posing risks to product quality and patient safety. Key issues included widespread non-microbial contamination such as grime, residue, and rust in production hoods and adjacent areas, impacting both sterile and non-sterile drug manufacturing. Poor aseptic techniques were noted, with operators handling open sterile units improperly, including tossing bottles and reaching into critical areas. A critical HEPA filter failure in an ISO-7 cleanroom went unaddressed, compromising sterile environments. Personnel were observed with exposed hair during aseptic operations. Furthermore, vermin, including live and dead insects, were found in warehouse and production component storage areas, directly linked to customer complaints of foreign matter in drug products. Disinfection protocols were inadequate, with insufficient contact times. Microbial contamination was a major concern, evidenced by a recall of veterinary transdermal gels due to mold (Penicillium sp, Aspergillus sp, Cladosporium sp) and mold recoveries in environmental monitoring which the firm had not fully investigated. Lastly, cleanroom certifications lacked comprehensive dynamic testing. These observations indicate a systemic failure to maintain controlled conditions and adhere to current Good Manufacturing Practices (CGMP), requiring the company to implement robust corrective and preventive actions to ensure the safety, quality, and sterility of its drug products.